Green Banana Peel Extract for Melasma Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Clinical analysis of Melasma
研究概览
简要总结
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.
详细描述
Objective
to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with melasma.
- •Patients aged 18 years or over and 60 years or less.
- •Patients who agree to participate in the study. -
排除标准
- •Patients who have other types of facial hyperchromia.
- •Patients who give up, for any reason, to continue treatment.
- •Patients who have any type of allergic reaction to the product.
结局指标
主要结局
Clinical analysis of Melasma
时间窗: 3 months
Analysis of the skin affected by Melasma will be performed with Melasma Area Severity Index (MASI), the most commonly used outcome measure for melasma.
Quality of life analysis
时间窗: 3 months
Analysis of the quality of life of Melasma patients during the study will be performed using the MELASQol Instrument. It is a useful tool in assessing quality of life in patients with melasma.
次要结局
未报告次要终点
研究者
Adriana Rodrigues dos Anjos Mendonça
Principal Investigator
Universidade do Vale do Sapucai